Otitis ExternaPhase 1/2NCT00872209
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
A Phase 1/2 study testing 0.3% Ciprofloxacin Ear Drops and 0.3% Ciprofloxacin Foam Otic Cipro in people with Otitis Externa and Otorhinolaryngologic Diseases, run by Otic Pharma at 4 sites in Israel.
Trial summary
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin. The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases
- What is being tested?
- 0.3% Ciprofloxacin Ear Drops and 0.3% Ciprofloxacin Foam Otic Cipro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesIsrael
- Study dates
- May 2009to Nov 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older eligible to sign by themselves.
- Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- Intact tympanic membrane
- Unilateral Acute Otitis Externa
Who cannot join
- Known allergy or sensitivity to Ciprofloxacin or other quinolones.
- Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
- Patient has the non intact tympanic membrane.
- Patient has a serious underlying disease.
- Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
- Patients with history of Diabetes mellitus.
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- Bilateral Acute Otitis Externa.
- Patients with more than 80% of the ear canal occluded.
- Pregnant or lactating patients.
- Overt fungal Acute Otitis Externa.
- Local ear canal abnormalities such as abscess, granulation or polyps.
- Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
- Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
- Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
- Current Infection requiring systemic antimicrobial therapy.
- Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
HaEmek Medical Center
Afula
Wolfson Medical Center
Holon, 58100
Maccabi Healthcare Services
Tel Aviv, 68125
Assaf Harofeh Medical Center
Tsrifin, 70300
About this study
Official title: Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
Read the detailed description
Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.
- Conditions
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis
- Being tested
- 0.3% Ciprofloxacin Ear Drops, 0.3% Ciprofloxacin Foam Otic Cipro
- Keywords
- swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
- Medical subject headings
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis, Earache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% Ciprofloxacin Ear DropsDrug
Also called Ciloxan, Ciprofloxacin, Cipro
4 gtt BID for 7 days.
0.3% Ciprofloxacin Foam Otic CiproDrug
Also called Ciloxan, Ciprofloxacin, Cipro
1 application, BID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Ciloxan Ear Drops | Active comparator | Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops Receives: Drug: 0.3% Ciprofloxacin Ear Drops |
| Foam Otic Cipro | Experimental | Patients randomized to this study arm will receive the experimental product Receives: Drug: 0.3% Ciprofloxacin Foam Otic Cipro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
Measured: within 7 days after completion of treatment (BID, for 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otic Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yehudah Roth, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872209
- Sponsor's protocol ID
- OP-001-00
- Status last verified
- Dec 2009
- First submitted
- 29 Mar 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.
- ClinicalTrials.gov ID
- NCT00872209
- Acronym / sponsor ID
- OP-001-00
- Conditions
- Otitis Externa, Otorhinolaryngologic Diseases, Ear Diseases, Otitis
- Keywords
- swimmer's ear, ear drops, ear foam, otic foam, ear infection, ear pain, ear inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Otic PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
Detailed description
Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciloxan Ear Drops | Active comparator | Drug: 0.3% Ciprofloxacin Ear DropsCiloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops |
| Foam Otic Cipro | Experimental | Drug: 0.3% Ciprofloxacin Foam Otic CiproPatients randomized to this study arm will receive the experimental product |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 and older eligible to sign by themselves.
- Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- Intact tympanic membrane
- Unilateral Acute Otitis Externa
Key exclusion criteria (17 listed)
- Known allergy or sensitivity to Ciprofloxacin or other quinolones.
- Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
- Patient has the non intact tympanic membrane.
- Patient has a serious underlying disease.
- Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3% Ciprofloxacin Ear DropsAlso: Ciloxan, Ciprofloxacin, Cipro4 gtt BID for 7 days. | Drug | Ciloxan Ear Drops |
| 0.3% Ciprofloxacin Foam Otic CiproAlso: Ciloxan, Ciprofloxacin, Cipro1 application, BID for 7 days | Drug | Foam Otic Cipro |
Primary outcome
Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
Time frame: within 7 days after completion of treatment (BID, for 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehudah Roth, MD principal investigator
Edith Wolfson Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.3% Ciprofloxacin Ear Drops and 0.3% Ciprofloxacin Foam Otic Cipro in people with Otitis Externa and Otorhinolaryngologic Diseases, run by Otic Pharma at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion (time frame: within 7 days after completion of treatment (BID, for 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.